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Panel Recommends Approval of Talc for Malignant Pleural Effusions

Panel Recommends Approval of Talc for Malignant Pleural Effusions

February 01, 1996

BETHESDA, Md--The Oncologic Drugs Advisory Committee (ODAC) has
recommended that Sclerosol (sterile aerosol talc) be approved
for use in relieving fluid around the lungs (malignant pleural
effusion) of patients with cancer. The sponsor for Sclerosol,
Bryan Corporation (Woburn, Mass), presented nine controlled trials
(six articles and three abstracts), with an average of 12 patients
each, in support of the talc.

In his presentation for Byran, John F. Beamis, MD, head, Pulmonary
and Critical Care Medicine, Lahey Hitchcock Clinic, Burlington,
Mass, cited his study of 11 patients, showing a 90% success rate,
defined as no return of fluid after 30 and 90 days based on chest
x-rays. None of the patients had recurrence of malignant pleural
effusion after 1 month.

When asked about the talc's origins and freedom from asbestos,
Frank Abrano, president of Bryan Corporation, said that the talc
comes from a mine in France and is chemically tested in Massachusetts
to be sure that it is asbestos-free. He added that this talc is
also used in food processing in the United States. Dr. Beamis
said that not only is the talc sterile but it is delivered directly
into the chest during thoracoscopy, with no systemic distribution
to other organs.

Lydia Larson, PharmD, speaking for the FDA, said that the talc
has been used as a pleural sclerosing agent since the 1950s. Its
use declined with the availability of injectable tetracycline,
then increased again when tetracycline was taken off the market.

Dr. Larson searched three databases and found 12 controlled clinical
trials of the talc, covering a variety of tumors, including lung,
ovarian, and breast. In all articles except one, a single dose
of the talc was administered.

The success rate, defined as no re-accumulation of fluid on 3
to 12 months' follow-up by x-ray, was 90% to 100% with the talc
vs 40% to 50% with other therapies. The symptomatic relief rate
with the talc was 9 of 9 in one study, and 6 of 7 in another.
Adverse effects included a 23% incidence of fever or pain and
up to a 1% incidence of infection.

Although the data on Sclerosol were mostly literature-based, and
the trials had small sample sizes and a variability of doses,
Dr. Larson pointed out that four of the trials were prospective
randomized studies, and that the trials showed an objective measure
of success in the form of chest x-rays and a consistency of results
over time.